(a) Processing method. (1) The processing method shall be one that has been shown to yield consistently a specific, potent final product, free of properties that would adversely affect the product for its intended use throughout its dating period.
(2) Anti-IgG, -C3d (polyspecific) reagents and anti-IgG products may be colored green.
(3) Only that material which has been fully processed, thoroughly mixed in a single vessel, and filtered shall constitute a lot. Each lot shall be identified by a lot number.
(4) A lot may be subdivided into sublots which shall be identified by the lot number to which has been added a distinctive prefix or suffix. If lots are to be subdivided, the manufacturer shall include this information in the license application . The manufacturer shall describe the test specifications to verify that each sublot is identical to other sublots of the lot.
(b) Final containers and dropper assemblies. (1) Final containers and dropper assemblies shall be clean.
(2) Final containers and dropper pipettes shall be colorless and sufficiently transparent to permit observation of the contents for presence of particulate matter or increased turbidity.
(c) Date of manufacture. The date of manufacture shall be the date the manufacturer begins the last entire group of potency tests.
[50 FR 5579, Feb. 11, 1985, as amended at 50 FR 16474, Apr. 26, 1985; 65 FR 77499, Dec. 12, 2000; 67 FR 9587, Mar. 4, 2002]
(a) In addition to the applicable labeling requirements of §§ 610.62 through 610.65 and § 809.10 of this chapter, and in lieu of the requirements in §§ 610.60 and 610.61 of this chapter, the following requirements shall be met:
(1) Final container label—(i) Color coding. The main panel of the final container label of all Anti-IgG, -C3d (polyspecific) reagents shall be white or colorless and printing shall be solid dark contrasting lettering. The main panel of the final container label of all other Anti-Human Globulin reagents shall be black with solid white lettering. A logo or company name may be placed on the final container label; however, the logo or company name shall be located along the bottom or end of the label, outside of the main panel.
(ii) Required information. The proper name “Anti-Human Globulin” need not appear on the final container label provided the final container is distributed in a package and the package label bears the proper name. The final container label shall bear the following information:
(A) Name of the antibody or antibodies present as set forth in paragraph (a)(4) of this section. Anti-Human Globulin may contain one or more antibodies to either immunoglobulins or complement components but the name of each significant antibody must appear on the final container label (e.g., anti-C3b, -C3d, -C4d). The final container labels of polyspecific Anti-Human Globulin are not required to identify antibody specificities other than anti-IgG and anti-C3d but the reactivity of the Anti-Human Globulin shall be accurately described in the package insert.
(B) Name, address, and license number of the manufacturer.
(C) Lot number, including any sublot designations.
(D) Expiration date.
(E) Source of the product.
(F) Recommended storage temperature in degrees Celsius.
(G) Volume of product.
(H) Appropriate cautionary statement if the Anti-Human Globulin is not polyspecific. For example, “DOES NOT CONTAIN ANTIBODIES TO IMMUNOGLOBULINS” or “DOES NOT CONTAIN ANTIBODIES TO COMPLEMENT COMPONENTS.”
(I) If the final container is not enclosed in a package, all items required for a package label shall appear on the container label.
(iii) Lettering size. The type size for the designation of the specific antibody on the label of a final container shall be not less than 12 point, unless otherwise approved by the Director, Center for Biologics Evaluation and Research. The prefix anti- and other parts of the name such as polyspecific may appear in smaller type.
(iv) Visual inspection. When the label has been affixed to the final container, a sufficient area of the container shall remain uncovered for its full length or for no less than 5 millimeters of the lower circumference to permit inspection of the contents.
(2) Package label. The following items shall appear either on the package label or on the final container label if see-through packaging is used:
(i) Proper name of the product, and the name of the antibody or antibodies as listed in paragraph (a)(4) of this section.
(ii) Name, address (including ZIP code), and license number of the manufacturer.
(iii) Lot number, including any sublot designations.
(iv) Expiration date.
(v) Preservative(s) used and its concentration.
(vi) Number of containers, if more than one.
(vii) Recommended storage temperature in degrees Celsius.
(viii) Source of the product.
(ix) Reference to enclosed package insert.
(x) The statement: “For In Vitro Diagnostic Use.”
(xi) The statement: “Meets FDA Potency Requirements.”
(xii) A statement of an observable indication of an alteration of the product, e.g., turbidity, color change, precipitate, that may indicate possible deterioration of the product.
(xiii) Appropriate cautions.
(3) Package insert. Each final container of Anti-Human Globulin shall be accompanied by a package insert meeting the requirements of § 809.10 of this chapter. If two or more final containers requiring identical package inserts are placed in a single package, only one package insert per package is required.
(4) Names of antibodies. Anti-Human Globulin preparations may contain one or more of the antibody specificities listed in this paragraph as described in paragraph (a)(1)(ii)(A) of this section.
Antibody designation on
container label
| Definition
|
|---|
| (1) Anti-IgG, -C3d; Polyspecific | Contains anti-IgG and anti-C3d (may contain other anticomplement and anti-immunoglobulin antibodies).
|
| (2) Anti-IgG | Contains anti-IgG with no anti-complement activity (not necessarily gamma chain specific).
|
| (3) Anti-IgG; heavy chains | Contains only antibodies reactive against human gamma chains.
|
| (4) Anti-C3b | Contains only C3b antibodies with no anti-immunoglobulin activity. Note: The antibody produced in response to immunization is usually directed against the antigenic determinant which is located in the C3c subunit; some persons have called this antibody “anti-C3c.” In product labeling, this antibody should be designated anti-C3b.
|
| (5) Anti-C3d | Contains only C3d antibodies with no anti-immunoglobulin activity.
|
| (6) Anti-C4b | Contains only C4b antibodies with no anti-immunoglobulin activity.
|
| (7) Anti-C4d | Contains only C4d antibodies with no anti-immunoglobulin activity. |
(b) The applicant may provide the labeling information referenced in this section in the form of:
(1) A symbol accompanied by explanatory text adjacent to the symbol;
(2) A symbol not accompanied by adjacent explanatory text that:
(i) Is contained in a standard that FDA recognizes under its authority in section 514(c) of the Federal Food, Drug, and Cosmetic Act;
(ii) Is used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition; and
(iii) Is explained in a paper or electronic symbols glossary that is included in the labeling for the device and the labeling on or within the package containing the device bears a prominent and conspicuous statement identifying the location of the symbols glossary that is written in English or, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be used; or
(3) A symbol not accompanied by adjacent explanatory text that:
(i) Is established in a standard developed by a standards development organization (SDO);
(ii) Is not contained in a standard that is recognized by FDA under its authority in section 514(c) or is contained in a standard that is recognized by FDA but is not used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition;
(iii) Is determined by the manufacturer to be likely to be read and understood by the ordinary individual under customary conditions of purchase and use in compliance with section 502(c) of the Federal Food, Drug, and Cosmetic Act;
(iv) Is used according to the specifications for use of the symbol set forth in the SDO-developed standard; and
(v) Is explained in a paper or electronic symbols glossary that is included in the labeling for the device and the labeling on or within the package containing the device bears a prominent and conspicuous statement identifying the location of the symbols glossary that is written in English or, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be used.
(c) The use of symbols in device labeling to provide the labeling information referenced in paragraph (a) of this section which do not meet the requirements of paragraph (b) of this section renders a device misbranded under section 502(c) of the Federal Food, Drug, and Cosmetic Act.
(d) For purposes of paragraph (b) of this section:
(1) An SDO is an organization that is nationally or internationally recognized and that follows a process for standard development that is transparent, (i.e., open to public scrutiny), where the participation is balanced, where an appeals process is included, where the standard is not in conflict with any statute, regulation, or policy under which FDA operates, and where the standard is national or international in scope.
(2) The term “symbols glossary” means a compiled listing of:
(i) Each SDO-established symbol used in the labeling for the device;
(ii) The title and designation number of the SDO-developed standard containing the symbol;
(iii) The title of the symbol and its reference number, if any, in the standard; and
(iv) The meaning or explanatory text for the symbol as provided in the FDA recognition or, if FDA has not recognized the standard or portion of the standard in which the symbol is located or the symbol is not used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition, the explanatory text as provided in the standard.
[81 FR 38928, June 15, 2016]